510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090728Substantially Equivalent

Hyperglide Occlusion Balloon System

Ev3, Inc., Irvine CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090728 is the FDA 510(k) clearance record for HYPERGLIDE OCCLUSION BALLOON SYSTEM, a class II device, cleared for Ev3, Inc. on under FDA product code MJN (Catheter, Intravascular Occluding, Temporary). FDA records list 3 510(k) clearances for Ev3, Inc., from to . As of , FDA records show no recalls naming K090728.

Clearance record

Decision date
Received
(28 days to decision)
Product code
MJN Catheter, Intravascular Occluding, Temporary
Regulation
21 CFR 870.4450
Device class
Class II
Review panel
Cardiovascular
Applicant
Ev3, Inc. 9775 Toledo Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MJN

Trailing 12 months

FDA records hold no clearances under product code MJN in the trailing twelve months.

FDA records show no clearances under product code MJN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MJN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260